Thiotepa-Clofarabine-Busulfan With Allogeneic Stem Cell Transplant for High Risk Malignancies

Summary

Any time the words "you," "your," "I," or "me" appear, it is meant to apply to the potential participant.

The goal of this clinical research study is to learn if thiotepa, busulfan, and clofarabine, when given before an allogeneic (bone marrow , blood, or cord blood cells) or haploidentical (bone marrow) stem cell transplantation can help to control cancers of the bone marrow and lymph node system. The safety of this treatment will also be studied.

This is an investigational study. Thiotepa and clofarabine are FDA approved and commercially available for the treatment of leukemia. Busulfan is FDA approved and commercially available for use in stem cell transplantation. The combination of thiotepa, clofarabine, and busulfan together with a stem cell transplant is investigational.

Up to 60 participants will take part in this study. All will be enrolled at M. D. Anderson.

Conditions

• Stem Cell Transplantation
• Leukemia
• Lymphoma

Interventions

DRUG

Thiotepa

5 mg/kg through a central venous catheter (CVC) over 2 hours on Day -8.

DRUG

Clofarabine

40 mg/m\^2 through a central venous catheter (CVC) over 1 hour daily on 4 consecutive days (Days -6 through -3).

DRUG

Busulfan

Test dose of 0.5 mg/kg through a central venous catheter (CVC)over 30 minutes on Day -7. High dose 5,000 µMol-min through a central venous catheter (CVC) over 3 hours on Days -5, -4, and -3.

PROCEDURE

Allogeneic Stem Cell Transplantation

Infusion of stem cells through through a central venous catheter (CVC) On Day 0.

DRUG

Thymoglobulin (ATG)

1.25 mg/kg by vein on Day -4 and 1.75 mg/kg on Day -3.

DRUG

G-CSF (Filgrastim)

5 µg/kg Injection under the skin once a day, starting 1 week after transplant, until blood cell levels return to normal.

DRUG

Tacrolimus

Starting dose of 0.015 mg/kg (ideal body weight) as a 24 hour continuous infusion daily, to be changed to oral dosing when tolerated. Tacrolimus is to be tapered as indicated after transplant day 90, if no GVHD is present. Tacrolimus is adjusted trough level of 5-15 ng/mL.

DRUG

Methotrexate

5 mg/m2 by vein on Days 1, 3 and 6 and Day +11 post transplant. The Day 11 methotrexate dose may be held as indicated if mucositis is present.

DRUG

Cyclophosphamide

Post haploidentical stem cell transplant participants: 50 mg/kg by vein on Days + 3 and + 4.

DRUG

Mesna

Post haploidentical stem cell transplant participants: 10 mg/kg by vein just prior to the first dose of cyclophosphamide, repeated every 4 hours for a total of ten (10) doses.

Sponsors & Collaborators

• M.D. Anderson Cancer Center

  lead OTHER

Principal Investigators

• Kris M. Mahadeo, MD · M.D. Anderson Cancer Center

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Max Age

60 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2009-03-02

Primary Completion

2019-03-09

Completion

2019-03-09

FDA Drug

Yes

Countries

• United States

Study Locations